EU delays verdict on Takeda diabetes drug to July

LONDON (Reuters) - European regulators on Thursday put back a decision until July on whether Takeda Pharmaceutical's diabetes drug Actos should remain on the market or not due to a possible link to bladder cancer.

The European Medicines Agency (EMA), which had been due to deliver a verdict this week, said there were "still numerous issues that needed to be resolved" before it could make a recommendation on the drug's future use.

It will finalize its recommendation at the next monthly meeting of its experts in July.

Earlier this month both France and Germany suspended use of Actos and Competact -- which combines Actos and an older drug called metformin -- after an official French study found a link to a slightly increased risk of bladder cancer.

Other European countries, however, decided to hold fire pending a decision from the EMA.

The EMA said in a statement that its experts considered the French study strengthened the signal of a small increased risk of bladder cancer. But they also found the study had several methodological limitations.

In the United States, the Food and Drug Administration said last week it was adding information about the potential risk of bladder cancer after long-term use to the drug's label, while keeping the product on the market for the time being at least.

The FDA initiated a safety review of Actos last September, while its European counterpart started a probe in March.

Japan's health ministry said earlier this month it had no plans for a recall of the blockbuster product, which had global sales of 387.9 billion yen ($4.8 billion) in the year ended March 31, accounting for 27 percent of Takeda's revenue.

Actos belongs to the same drug class as GlaxoSmithKline's

Avandia, which was pulled from the market in Europe and had severe restrictions imposed on its use in the United States last September, after being linked to heart risks.

GSK's drug has not been associated with bladder cancer.

Actos was approved for use in Europe in 2000 but its potential bladder cancer risk, seen in tests of male rats, has long been a topic of discussion.